Active — Not RecruitingPhase 4

Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)

United States55 participantsStarted 2021-11-22

Plain-language summary

This study will evaluate changes in blood vessels around the heart (e.g., aorta and carotid arteries) and in the brain with the loss of female sex hormones (e.g., estrogen) during the menopause transition. The menopause transition is associated with declines in blood vessel function and increased risk for cardiovascular disease and Alzheimer's disease. Increasing evidence supports an early role for declines in blood vessel function and future development of Alzheimer's disease in aging men and women. This study will learn about the effects of changes in female sex hormones, such as estrogen, during the menopause transition on blood vessel around the heart and in the brain in women.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Healthy premenopausal, early perimenopausal and postmenopausal women will be recruited. Premenopausal women will have regular menstrual cycles, with no change in observed cycle length (21-35 days), confirmed by menstrual cycle calendars. Early perimenopausal will be defined as a change in cycle length of \>7 days from normal with no skipped periods and/or a FSH \<25 IU/L (with discretion of the study MD). Postmenopausal women will have gone through natural (i.e., non-surgical) menopause with \>12 months but \<6 years of amenorrhea. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels. Exclusion Criteria: * Seated resting blood pressure \>140/90 mmHg * Use of medications that might influence cardiovascular function or cerebral blood flow; * Pregnant, currently breastfeeding or intention to become pregnant in the next 6 months; * Use of menopausal therapy or hormonal contraceptives, etc. within the previous 3 months or intent to start during the study period; * BMI \>39 kg/m2; * Vigorous intensity exercise \>2 days per week; * Any current or past history of systemic illness that would interfere with study outcomes such as: diabetes, cancer (other than melanoma), liver, gallbladder disease, peripheral artery disease or thromboembolism, neurological disease, CVD or cerebrovascular disease; * Abnormal thyroid, liver, or kidney function testing d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Aortic stiffness and pulsatile hemodynamics

Timeframe: Change from baseline at 12 weeks

Trial details

NCT IDNCT05057546

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-18

View on ClinicalTrials.gov More Menopause trials